FDA grants fast track designation to Onivyde for small cell lung cancer
The FDA granted fast track designation to irinotecan liposome injection for treatment of certain patients with small cell lung cancer, according to the agent’s manufacturer.
The designation applies to use of the agent as second-line monotherapy for patients whose disease progressed after a first-line platinum-based regimen. The randomized phase 3 RESILIENT trial is underway to evaluate the efficacy and safety of this treatment strategy.
Irinotecan liposome injection (Onivyde, Ipsen), a topoisomerase 1 inhibitor, is approved in the United States for use in combination with 5-FU and leucovorin for treatment of patients with metastatic adenocarcinoma of the pancreas whose disease progressed after gemcitabine-based therapy.
Small cell lung cancer accounts for 10% to 15% of lung cancer cases in the United States. Approximately 70% of patients with small cell lung cancer have metastatic disease at the time of diagnosis.
“With this aggressive and often late-stage-diagnosed form of lung cancer, we are proud to be one step closer to making another treatment option available to patients,” Howard Mayer, MD, executive vice president and head of research and development at Ipsen, said in a company-issued press release.
The FDA previously granted fast track designation to irinotecan liposome injection for use with 5-FU, leucovorin and oxaliplatin for first-line treatment of patients with previously untreated, unresectable, locally advanced or metastatic pancreatic ductal adenocarcinoma.